Tixagevimab and cilgavimab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injection of tixagevimab and injection of cilgavimab.
These products have been produced by recombinant technology using Chinese Hamster Ovary (CHO) cell line.
Drugs List
Therapeutic Indications
Uses
Coronavirus disease 2019 (COVID-19) - treatment
Coronavirus disease 2019 (COVID-19): Prophylaxis
Tixagevimab and cilgavimab is indicated for the pre-exposure prophylaxis of COVID-19 in adults who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2 and who are unlikely to have an adequate immune response to COVID-19 vaccination.
Tixagevimab and cilgavimab is indicated for the pre-exposure prophylaxis of COVID-19 in adults who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2 and for whom COVID-19 vaccination is not recommended.
Tixagevimab and cilgavimab is indicated for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at an increased risk of progressing to severe COVID-19.
Dosage
Adults
Pre-exposure prophylaxis of COVID-19
300mg single dose-administered as separate sequential injections of 150mg tixagevimab and of 150mg cilgavimab.
Alternatively for some SARS-CoV-2 variants:
600mg single dose-administered as separate sequential injections of 300mg tixagevimab and of 300mg cilgavimab may be more appropriate for some SARS-CoV-2 variants.
Treatment of COVID-19
600mg single dose-administered as separate sequential injections of 300mg tixagevimab and of 300mg cilgavimab.
Tixagevimab and cilgavimab should be given within 7 days of the onset of symptoms of COVID-19.
Additional Dosage Information
Tixagevimab with cilgavimab has only been studied in single-dose studies.
Administration
For intramuscular injection only.
Tixagevimab and cilgavimab must be given as separate sequential intramuscular injections at different injection sites in two different muscles, preferably in the gluteal muscles. The order in which the two ingredients are administered does not matter.
Contraindications
Children under 18 years
Precautions and Warnings
Predisposition to thromboembolic disease
Within 2 weeks of COVID-19 vaccination
Breastfeeding
Cardiovascular disorder
Coagulopathy
Pregnancy
Thrombocytopenia
Consult national/regional policy on the use of anti-infectives
Treatment to be initiated and supervised by a specialist
Discard any unused portion
Do not use if solution is discoloured or particulates are apparent
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Advise patient of thromboembolic symptoms and to report them if they occur
Monitor for hypersensitivity reactions for 1 hour after administration
Prophylaxis: Advise patient to report signs/symptoms of COVID-19 infection
Prophylaxis: COVID-19 breakthrough infection can occur
Discontinue if severe hypersensitivity reactions occur
Advise patients to report any new or worsening cardiovascular symptoms
Pregnancy and Lactation
Pregnancy
Use tixagevimab and cilgavimab with caution during pregnancy.
The manufacturer advises that tixagevimab and cilgavimab may be used during pregnancy where the expected benefit to the mother justifies the potential risk to the foetus.
At the time of writing there is limited data from the use of tixagevimab and cilgavimab during pregnancy. No off-target binding was detected in a cross-reactive binding assay using a protein array enriched for human embryofoetal proteins. As tixagevimab and cilgavimab are both human immunoglobulins G (IgG), they have the potential for placental transfer from the mother to the developing foetus, the potential prophylactic benefit or risk to the foetus is unknown.
Lactation
Use tixagevimab and cilgavimab with caution during breastfeeding.
The manufacturer recommends that decisions on whether to breastfeed during treatment or to abstain from tixagevimab and cilgavimab therapy should take into account the benefit of breastfeeding for the child and the benefit of therapy for the women.
At the time of writing, there are no data on the excretion of tixagevimab and cilgavimab in human milk. Effects on the exposed infant is unknown.
Side Effects
Anaphylaxis
Arrhythmias
Cardiac failure
Erythema at injection site
Hypersensitivity reactions
Induration (injection site)
Injection site reactions
Itching (injection site)
Local pain (injection site)
Myocardial infarction
Peripheral artery thrombosis
Portal vein thrombosis
Pulmonary embolism
Rash
Superior sagittal sinus thrombosis
Urticaria
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: November 2022
Reference Sources
Summary of Product Characteristics: Evusheld 150mg/150mg solution for injection. AstraZeneca UK Limited. Revised November 2022.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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